Replies to post #291722 on Amarin Corp Plc (AMRN)

[Meowza]

Yes. Just because they feel like it.

[rafunrafun]

While the district's court language is imperfect, the presumption of validity does not relieve the patentee of any responsibility to set forth evidence in opposition to a challenger’s prima facie case which, if left unrebutted, would be sufficient to establish obviousness

Where and how does this address the crux of the argument: weighing SCs against each other?

[johnking29]

YES - Yet like Novo, the Judges will review how the sides got to the SC's meaning what was used by the Judge to determine the Patent was Obvious first and foremost.

One of the arguments in Amarins case is the flawed info Due was provided to find the Patent Obvious. The examples she used were flawed science whereas the info in the Novo case was determined to not be flawed. The Patent Office also rejected the Novo Patent 4 times before approving it - a much different case than ours and a much higher hurdle for Novo...

Even in the Novo case one of the Judges questioned the evidence used to determine that the Patent was obvious to be sure it was not flawed asking if the evidence was intentionally altered to help the Generics:

"Dr. Sturis was accused of failing to notify the PTO that the original test plan did not include his data calculations at 120 minutes. The Federal Circuit found it to be a nonmaterial omission because it did not qualify as “but-for” material. The Court explained that this was not a case in which adverse results were hidden in favor of more positive data, nor did the omission undermine the opinion stated in the declaration."

In short - the Judges should go back to first make sure the determination that the Patent was deemed Obvious was not a flawed decision (as they did with the Novo decision) then they review the SC's to see if they were properly applied...

Singer will fight the decision that found the Patent obvious because the Generic's Cropped the data to bolster their position on a document they used to help their case... ADVERSE RESULTS WERE HIDDEN and IT UNDERMINED THE DECISION BY THE JUDGE AND WAS (most likely) INTENTIONAL!

[vtem01]

Other,

Seems like you’re contradicting yourself, presumption of validity means the defendants need to prove otherwise and therefore Du’s bias !?

[HinduKush]

"While the district's court language is imperfect, the presumption of validity does not relieve the patentee of any responsibility to set forth evidence in opposition to a challenger’s prima facie case which, if left unrebutted, would be sufficient to establish obviousness."

In Zup the CAFC panel lays out how the burden of proof should fall:

Any concerns regarding improper burden allocation
can be quickly dismissed. Our precedent is clear that “the
burden of persuasion remains with the challenger during
litigation because every issued patent is entitled to a
presumption of validity[.” Novo Nordisk A/S v. Caraco
Pharm. Labs., Ltd., 719 F.3d 1346, 1353 (Fed. Cir. 2013).While this burden of persuasion remains with the challenger,
a patentee bears the burden of production with
respect to evidence of secondary considerations of nonobviousness.
Here, the district court adhered to our
precedent in analyzing the evidence presented. Although
ZUP takes issue with the court’s statement that “ZUP has
failed to establish either that a long-felt but unresolved
need existed in the water recreational device industry or
that its product somehow solved any such need,”

I agree with Zip's conclusions:
1. The Generics can't persuasively negate the clear error in the law by judge Du in weighing negative vs. positive S.C.
2. the Generics can't persuasively negate the clear errors of fact made in Mori and Kura by judge Du.
3. The Generics have to fall back on arguments that the effect of the S.C. was unimportant in this case...and that the errors of fact in the prima facie evidence "were not really (serious) errors".
4. these arguments by the Generics are not convincing.

For me as non-legal reader these patent appeal cases are very interesting, because each one turns on a different analytical point e.g in either prima facie obviousness analysis errors, or lack of one of several secondary objective indicia. For example in Zup the absence of demonstrable unresolved long felt unmet need was the determinitive issue. In Amrn's case, it is the the Unexpected Benefit which is/will be the clincher and IS the reason why you cannot assign a point system to the SC objective indicia, becuase the relative weighting of the SC's varies with the facts of each case. One cannot simply assign points add, subtract, and play off each other to get the answer. Unless your are a simpleton.....